Aims. Heart failure (HF) is one of the most common causes of hospitalization, has high mortality and represents
an economic burden. The Heart Failure Disease Management Program (HFDMP) at Health Sciences North (HSN)
was designed and implemented utilizing various outpatient strategies aimed to help patients avoid emergency
department (ED) visits, lower HF hospitalizations, improve outcomes, decrease mortality and lower health care
costs. This study was designed to evaluate the effectiveness and safety of this program.Methods and results. 138 patients were enrolled in the HFDMP over a period of 12-months. Patient outcomes,
admission, readmission and mortality rates were observed to determine the safety, efficacy and the costs associated.
Of the patients treated for acute decompensated HF (ADHF) 29 patients received 79 continuous intravenous
furosemide therapy (infusions). These patients were monitored for electrolyte changes, ED visits and hospitalizations
to determine the safety and efficacy of the infusion clinic (IC). During the period of study NT-proBNP, eGFR and
ejection fraction among other variables were analyzed. Only five readmissions within 30 days were noted over 12
months however, none of these hospitalizations was related to ADHF. The program’s mortality rate was 3%. No
patient subjected to infusions required an ED visit or hospitalization. No clinical significant electrolyte changes
was seen requiring hospitalization.Conclusions. The findings from our study suggests that this outpatient approach is a safe way to manage ADHF
and an effective way to avoid ED visits, lower HF hospitalizations, decrease mortality, improve clinical symptoms
and lower health care utilization costs.

Patients with heart failure (HF) are typically adults with
multiple concurrent diagnoses, complex drug regimens
and significant disease management challenges1.
Approximately seven million North-Americans2, 4.2
million South Americans3 and 15 million Europeans4
are living with HF: one of the most common causes
of hospitalization and readmission worldwide5. In
Canada, hospital readmission rates for HF remain high
at approximately 9% at 30 days and 15% at 90 days6.
It is estimated that readmission rates cost the Canadian
healthcare system as much as $1.8 billion per year7 and
that up to 59% of those readmissions could have been
avoided by improving the care patients receive before
and after discharge.
In response to the burden of care as it relates to repeated
hospital readmissions and emergency department (ED)
visits due to acute decompensated heart failure (ADHF),
there have been several publications with regards to
strategies that address the post-hospitalization needs
of patients and their ability to mitigate readmission
risk8. HF management programs vary in complexity
and models9,10. Currently, there is no clearly defined
model to achieve the best possible clinical outcomes and
decrease the cost of the burden of care. Characteristics
of the most effective programs have been identified but
are extremely broad11-13. Furthermore, evidence of the
effectiveness and safety of the use of IV diuretic therapy
in a non-emergency setting is still very limited8,14 and
requires further investigation.
The Heart Failure Disease Management Program (HFDMP) at Health Sciences North (HSN) was
developed as an outpatient strategy aimed to reduce
hospitalizations and re-hospitalizations, ED visits and
improve clinical outcomes. This programs’ model was
established combining several successful strategies
reported in the literature for HF management, including
an infusion clinic (IC) so that patients in ADHF may
receive continuous intravenous (IV) diuretic therapy
(infusions) for symptomatic volume overload who
would otherwise have had to visit an ED or be admitted
to the hospital.
This work aims to describe the HFDMP approach to
outpatient management of HF. We intend to determine
indicators of effectiveness of the HFDMP including the
safety and efficacy of the IV diuretic component of the
program. Specifically, we intend to determine the ability
of HFDMP to manage acutely decompensated episodes
of HF in an outpatient setting, while at the same time
decreasing the need for patients to visit the ED and
thereby decreasing admissions and readmissions rates
while cutting health care related expenditures and
improving patient outcomes. Furthermore, we aim to
determine if the IC is a safe way to manage ADHF with
the use of IV diuretic therapy in an outpatient setting.

Methods

Study population Study population consisted of patients referred to the
HFDMP at HSN between July 2012 and July 2013.
Subjects admitted to the HFDMP were HF patients
at high risk of hospitalization. These patients were
referred from general practitioners, cardiologists or other
clinicians. There were no restriction criteria for referralto this program. All patients referred and enrolled in the
program during the period of study were included in this
analysis. No sample size calculation was used since there
was no restriction to the number of patients to include in
this program’s 12-month evaluation. Subjects included
were only limited to the total number of patients enrolled
in the HFDMP in that year.
All patients had a diagnosis of chronic HF - according to
the Framingham criteria15; and were classified according
to functional capacity (NYHA) and limited to those
that continued their treatment in HFDMP during the
entire period of the study. Those who only attended the
initial visit and did not attend subsequent scheduled
visits were excluded. No other exclusion criteria were
applied for this analysis.
To assess the effectiveness of the HFDMP, we have
compared both the HFDMP and HSNs admission,
readmission and mortality rates as well as patient
outcomes for the same period. Finally, patients included
were divided into two groups according to the treatment
modality they underwent in the program: infused group
(those that during the study had symptomatic volume
overload, signs and symptoms of ADHF and required
intervention with IV diuretic therapy); and non-infused
group (patients treated in the program that did not
require IV diuretic therapy during the same period).
This was aimed to determine the safety and efficacy
of the different treatment approaches provided by the
program. This study complies with the declaration of
Helsinki; the appointed ethics committee has approved
the research protocol (#930).

Clinical intervention The HFDMP at HSN consisted of a multidisciplinary
program for outpatients at high risk of hospitalization.
Patients included received at their first visit a thorough
clinical assessment by a cardiologist. Medical
management of the patient included up or down titration
of medications according to evidence-based guidelines;
medication reconciliation, self-care education and
support for patients and their families, psychosocial
care, advanced care planning and palliative care.
Other features of the program included telemonitoring,
nurse-led telephone-based chronic care services for
symptom monitoring and management, medication
counseling, health education and self-care coaching,
ongoing assessment of maximal exercise capacity and
functional capacity, peak VO2, six-minute walking tests,
sleep apnea testing, assessment of cardiac function and
referral to cardiac and pulmonary rehabilitation. Selfcare
for HF encompasses a spectrum of behaviours
ranging from adherence to medication, exercises, diet
recommendations, recognition of early warning signs
of HF, what to do and when to call the HFDMP. The
ability of patients and families to be able to call the
clinic at any time to discuss concerns is considered a
key component of this program.

Infusion clinic During the period of this study if a patient had
complaints of weight gain, increased dyspnea, cough,
orthopnea or paroxysmal nocturnal dyspnea (PND)
and/or increased edema, the patient was instructed to
up-titrate their oral loop diuretic for 24-48 hours and an
appointment was booked within that timeframe in the
HFDMP. If the patient experienced ongoing signs and
symptoms of ADHF, the patient was instructed to report
in to the HFDMP for evaluation and treatment (infused
group). Patients were given an IV bolus of a loop
diuretic followed by a continuous infusion. After the
patient’s treatment, a decision was then made whether
the patient would return the following day for continued
IV loop diuretic treatment or be seen in the program
for ongoing follow up. Patients requiring more than one
day of IV diuretic therapy were discharged home at the
end of the day and asked to return to the HFDMP the
following day for ongoing treatment and monitoring.
All treatments included IV furosemide with an initial
bolus dose of 40 - 100 mg over 10 minutes followed
by a continuous IV infusion rate between 10 - 40 mg/
hr. The dosage administrated was determined based
on the estimated glomerular filtration rate (eGFR) of
the patient. Depending on the patient specific diuretic
needs, patients might have also received metolazone
concomitantly. The duration of the continuous IV
infusion typically lasted six to eight hours.

Outcome data collection Outcome measures were collected for each patient at
baseline, 30 days, 3 and 6 months after enrolment in
the program. The clinical characteristics, lab values
and other variables of patients included in the study
both pre-and post intervention were collected. The
changes over time in selected variables, such as ejection
fraction (EF), N-Terminal Pro B Natriuretic Peptide
(NT-proBNP), eGFR, sodium (Na+), potassium (K+)
and creatinine (Cr) were documented. Data collection
also included the number of ADHF episodes, number of
visits to the ED for any reason, HF admissions, 30-day
readmission rates and mortality rates during the period
of study. ED rates, HF readmission and admission
rates as well as mortality rates were also collected for
HSN’s HF patients not attending the HFDMP from the
Electronic Medical Record (EMR).

Safety and efficacy of the infusion clinic Through the use of the IC we hoped to eliminate the need
for ED visits and subsequent hospitalizations in patients
actively enrolled in HFDMP. To evaluate the efficacy
of the IC we have documented the number of patients
that received continuous IV furosemide therapy during
the period of the study. We have determined the number
of infusions these patients received and calculated thenumber of ED visits and/or hospitalizations that were
avoided through this method. One episode of ADHF
treated in the outpatient setting (with either single or
multiple infusions) and subsequent discharge home
without having to be admitted or attend an ED, was
considered one ED/hospitalization avoidance. The
admission and readmission rates for ADHF for patients
enrolled in the HFDMP were determined, and compared
to HSN’s admission and readmission rates for patients
not attending the program, in the same period.
To evaluate the safety of the IC we recorded pre and
post intervention changes in creatinine, sodium and
potassium levels before and after each infusion. Adverse
reactions such as infection at IV site, hypotension,
dizziness, tinnitus or hearing impairment as well as
any other complications were documented to determine
the safety of this treatment approach. Urine output was
measured non-invasively or invasively for all patients.
Finally, the number of patients that required transfer
to ED and/or admission after treatment in the IC was
determined.

Statistical analysis Descriptive and inferential statistics were used to explore
the relationship between the independent and dependent
variables. Chi-square was used for categorical variables
and one-way ANOVA for continuous variables. Timedependent
morbidity and mortality data of the 138
patients was used to construct Kaplan-Meier eventfree
survival curves for the sample set. Analysis were
conducted using SPSS (v17). Statistical significance
was set at p<0.05.

Results

1- Demographics and clinical characteristics of
patient groups A total of 167 patients were referred to the HFDMP
during the period of this study. After the initial
assessment, 29 patients did not return for any
subsequent visits and were excluded from the study. The
main reasons patients did not continue with HFDMP
were personal preference and wanting to continue
treatment with their usual cardiologist, and/or patients
lived too far from the clinic. Therefore, a total of 138
patients were followed by the HFDMP program for
at least 12 months and were included in the analysis.
Patient demographics and clinical characteristics at
enrolment (T1) can be found in Table 1. The mean age of
included patients was 74.6 years; 50% (n=69) of patients
had reduced EF [left ventricular ejection fraction (LVEF)
≤40%] at enrolment. The NYHA functional classification
of patients was as follows: Class I 7.9% (n=11); Class II
45.7% (n=63); Class III 43.5% (n=60) Class IV 3% (n=4)
at T1. Participant comorbidities can be found in Table 2.
The most common comorbidities were as follows: 84.1%
(n=116) hypertension, 76.1% (n=105) dyslipidemia and
52.2% (n=72) had type II diabetes, 26.9% (n=36) had
chronic kidney disease.

Twenty-nine patients were treated with intravenousdiuretic therapy in the IC during the period of this study (infused group). The remaining 109 patients were
followed in the HFDMP during the study and did not
require an infusion (non-infused group).

2- Safety and efficacy of the HFDMP
2.1- Infusion clinic Of 138 patients followed in the HFDMP during the
12 month period, 29 patients (infused group) received
outpatient continuous intravenous furosemide therapy
for ADHF. A total of 79 infusions were done on
these patients. All patients experienced relief of their
symptoms and reported an overall improvement in their
dyspnea. All patients were discharged from the IC to
their homes after treatments. No patient that attended
the IC required transfer to the ED or admission to the
hospital for their ADHF episode.

2.2- Safety of the infusion clinic No incidence of clinically significant electrolyte
disturbances was noted for the patients that attended
the IC. There was no ED visits or admissions as a result
of the infusion treatment in the IC. Renal function
values were obtained before and after each infusion. No
significant change was seen in the measured variables
in all the treatments performed as seen in Figure 1.

2.3- EF, NT-proBNP and eGFR assessments Changes in clinical indicators with progression of
treatment in the program can be seen in Figure 2.
Notably, the levels of NT-proBNP for all patients at time of enrolment (T1) in the program was 3214
ng/L. Three months after enrolment (T2) there was a
significant decrease in the levels of NT-proBNP to 2109
ng/L (p<0.05). In the non-infused group, NT-proBNP
at baseline was 3072 ng/L and decreased to 2124 ng/L
(p<0.05) for the same period. For the infused group,
NT-proBNP levels were 3772 ng/L at baseline and a
decrease to 2056 ng/L (p<0.05) was found at 3 months’
post intervention. The mean EF in the infused group was
42% at T1 and increased to 58% at 3-6 months’ post
intervention. The mean EF for the non-infused group
was 43% at baseline and increased to 51% in the same
period. Finally, the eGFR of the infused group was 45
mL/min at baseline and remained relatively stable (48
mL/min) 3 months’ post intervention. As for the noninfused
group, eGFR decreased from 47.5 mL/min at
baseline to 43.5 mL/min with no clinical significance.

2.4- Distribution of admissions and re-admissions From July 2012 to July 2013 the total number of
hospitalizations at HSN with a primary diagnosis of
HF was 295. Of 295 admissions, 18 admissions were
patients from HFDMP and 277 admissions were from
patients not enrolled in the program. In the same period,
there were 60 readmissions within 30 days at HSN; 5
of which were patients enrolled in the HFDMP. Of the
55 readmissions for patients not attending the HFDMP,
20 were HF related. Notably, of the 5 readmissions for
patients enrolled in the program, zero was due to ADHF.

2.5- Mortality Mortality rate for the HFDMP was 3% (4/138) during
the 12-month period of follow-up. One patient (0.7%)
had a cardiovascular related cause of death (Table 3).
We have determined the mortality rate and causes of
death for the excluded patients from this study (n=29),
identified by HSN´s electronic medical records. For
these patients, 21% (n=6) died in the same period of
the study and 14% (n=4) experienced a cardiovascular
related cause of death.

Table 3. Mortality rates

Discussion

Heart failure has a significant impact on patients’ lives
and is responsible for high costs within our healthcare
system. This problem needs to be addressed with more
effective treatment approaches. Data obtained from
the Decision Support department at HSN states that
between 2006-2012 the 30-day HF readmission rate
was 30% at HSN. This figure is over the international
reported average 16. The average length of stay at HSN
for a patient admitted with HF is 10.8 days, equating
to approximately $1000/day17, which translates into a
considerable high burden of healthcare costs for this
patient population. The introduction of the HFDMP at
HSN was an attempt to address this problem. Although,
there are several studies on HF disease management
programs and clinics12,18 there still exists a lack of
published standards/guidelines on care processes and
structural elements of such programs. Our program
was established following HFSA19 and ACC/AHA20
guidelines and in line with the European Society of
Cardiology11 (ESC) recommendations for HF clinics.
However, all recommendations do not provide specific
details about the characteristics of the clinics themselves.
We decided to incorporate in our programs’ model
several combined approaches for HF management as
reported in the literature. Such considerations should be
a cardiologist to help manage care21,22, telemonitoring23,
and the implementation of outpatient diuretic therapy
clinics for the treatment of ADHF24,25.
Improved patient outcomes were demonstrated when a
cardiologist participates and leads the management of
treatment for a patient in a HFDMP21. In the HFDMP
there is a lead cardiologist. This standard of care has
proven to be particularly significant when there is a
close interaction between the HFDMP and the primary
care physician (up to 40% reduction in mortality,
or mortality combined with hospitalization) when
compared to patients that were managed solely by their
primary care physician22.
We have incorporated telemonitoring23 for patients
who have difficulty accessing specialized care because
of geography, transportation, or infirmity26. Studies
have demonstrated that isolated telephone-based care
services in HF populations does not help to decrease
the rate of readmission or death when compared with
usual care (HF programs without telemonitoring)27,28.
Telemonitoring improves patient outcomes significantly
in HF populations when provided in the context of a
broader disease management program29, which is one
of the guiding principles of our program.
The ability to provide outpatient intravenous diuretic
therapy is a key element in the HFDMP. The IC allows
an alternative to hospitalization for the treatment
of patients with ADHF. Although innovative and
potentially effective, the safety of providing IV diuretic
therapy in an outpatient setting (and discharging patients
home the same day) needs to be further investigated.
Additionally, this study sought to evaluate the programs
ability to improve patients’ clinical indicators over time,
to determine the safety and efficacy of this model of care
and whether a combination of strategies to try and reduceADHF would lower HF mortality, prevent ED visits for
ADHF and lower admission and readmissions rates.
The safety and efficacy of the patients in the HFDMP
(infused or not) maintained a stable eGFR over time,
% of EF improved, and NT-proBNP values decreased
over time.
Patients who required IV loop diuretics (infused group)
had the best response to the treatment. Our results
demonstrated that the use of IV loop diuretics (with or
without metolazone) was effective in reducing edema
and dyspnea without negatively affecting electrolyte
balance in an outpatient setting. No significant adverse
effects were noted in our study when patients were
infused in the IC. Of note, when we looked at all HF
admissions at HSN, 30-day readmission for all causes
and 30-day readmission with a primary diagnosis of HF
at HSN, there was evidence to support that the IC at the
HFDMP had a positive impact on decreasing ED visits
and admissions. Only a small percentage of all HSN´s
HF admissions and 30-day readmission rate were for
patients enrolled in the HFDMP (18/295 admissions and
5/60 readmissions within 30-days). Furthermore, the
program did not have a single 30-day readmission due
to ADHF (0/5), compared to 33% (20/60) readmissions
with a primary diagnosis of HF for patients not attending
the program. We consider this to be a strong indicator
that utilization of the HFDMP has a potential to decrease
ED visits, admissions and readmissions and decrease
healthcare utilization costs.
Despite advances in HF management, mortality
associated with this disease remains high. The estimated
1-year mortality varies between 20 to 30%30 while other
reports cite an estimate of 1-year mortality at 11%31. The
1-year mortality rate for patients enrolled in the HFDMP
was calculated to be 3% for all causes. Furthermore,
only a single case was related to a cardiovascular cause
of death. The mortality rate for patients that were not
included in our study (patients assessed at baseline in
HFDMP but lost to follow-up) was 21% for the same
period, which is comparable to the international reported
average for 1-year HF mortality rates30. Furthermore,
in these patients 14% died from cardiovascular related
causes. Although a direct comparison of these figures
have several limitations, our study suggests that the
mortality rates of patients enrolled in the HFDMP were
significantly lower compared to those patients who
were lost to follow-up. The same can be said about the
program´s effect on decreasing the burden of health
care costs. Although this study was not designed to
measure cost savings for the hospital as it relates to the
burden of care for HF, the data would suggest that the
program had a positive impact on cost savings for the
hospital by reducing HF admissions and readmissions
and by decreasing the average length of stay. Based
on the aforementioned data above we could infer that
the HFDMP may have saved over one million dollars.
However, this would need to be further verified through
specific case costing data.

Conclusions

All these indicators show that this multidisciplinary model
for HF management, including the infusion clinic appear
to be a safe, efficacious and cost-effective program when
compared with current HF standards (ED and inpatient
treatment for patients with HF requiring diuretic therapy)
and other HF clinic models. The infusion of loop diuretics
to HF patients in an outpatient setting is an effective and
well-tolerated treatment option for patients but also plays
a role preventing unnecessary ED visits and hospital
admissions and readmissions. The cost savings based on
the number of HF admissions in a given year, length of
stay and average cost per patient admission is substantial.
Lastly, the open access granted to patients to be able to
speak to someone in the HFDMP in a timely fashion
allows patients to be triaged, assessed and managed
safely and efficaciously in an outpatient setting prior
to an acute decompensation requiring an ED visit or
hospital admission. We believe this aspect to be one of
the cornerstones of the success of the HFDMP.
The findings of the present study also has its limitations.
This is a single-center experience; therefore, the findings
may not be generalized to other HF populations.
Comparisons of the mortality rates between included
and excluded patients have to be interpreted as indicative
(and not conclusive) since variables were not under
control for the excluded patients. Regardless of these
aspects, our data suggests that the HFDMP at HSN is
considered to be safe and provides an alternative solution
for ADHF management outside of inpatient hospital
settings. Furthermore, this study has demonstrated that this
model of care could provide an effective way of avoiding
unnecessary emergency visits and hospitalizations with
important cost saving implications.

Acknowledgments

A.C.V., P.Z and K.K. designed the study. A.C.V is
director of the HFDMP and responsible for the project
and. P.Z. and K.K. collected the data. P.Z, A.C.V. and
M.C. analyzed the data. P.Z. and A.C.V prepared the
manuscript and all authors edited and approved the
manuscript.